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First received: February 13, 2023

Clinical Trial: A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.

Study Status: Completed

Recruit Status: RECRUITING

Condition: Primary Prevention of Atherosclerotic Cardiovascular Disease

Study Type: INTERVENTIONAL


Official Title: A Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Effect of Inclisiran on Preventing Major Adverse Cardiovascular Events in High-risk Primary Prevention Patients (VICTOR

Brief Summary: CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic…

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